CVS MAXIMUM REDNESS RELIEF- glycerin, naphazoline hci solution/ drops

CVS Maximum Redness Relief by

Drug Labeling and Warnings

CVS Maximum Redness Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc., KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%

PURPOSE

Purposes

Glycerin....Lubricant

Naphazoline HCl....Redness Reliever

INDICATIONS & USAGE

Uses

for the relief of redness of the eye due to minor eye irritations

for the temporary relief of burning and irritation due to dryness of the eye

for use as a protectant against further irritation or dryness of the eye

Warnings

For external use only

Do not use

Do not use if solution changes color or becomes cloudy

Ask a doctor before use if you have narrow angle glaucoma

When using this product

to avoid contamination, do not touch tip of container to any surface

replace cap after using

overuse may produce increased redness of the eye

pupils may become enlarged temporarily

Stop use and ask a doctor if

you experience eye pain

you experience changes in vision

you experience continued redness or irritation of the eye

the condition worsens or persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

OTHER SAFETY INFORMATION

Other information

store at room temperature

remove contact lenses before using

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS MAXIMUM REDNESS RELIEF 
glycerin, naphazoline hci solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-837
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.03 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-837-01	1 in 1 BOX	03/24/2023
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	03/24/2023

Labeler - CVS Pharmacy, Inc. (062312574)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(51316-837) , pack(51316-837) , label(51316-837)